Storage Conditions

Spectrum

Impurity Profile

Lamivudine Enantiomer: Not more than 0.3%Impurity 1 (0.4 Ret. Time): Not more than 0.3%Impurity 2 (0.9 Ret. Time): Not more than 0.2%Salicylic Acid: Not more than 0.1%Individual impurity: Not more than 0.1%Total impurities: Not more than 0.6%

Water Content (Karl Fischer)

Not more than 0.2%

Absorbance

(440nm): Not more than 0.0015

Melting Point

175 - 179°C

Optical Rotation

-135.0 - -145.0°

Assay

98.0 - 102.0%

Loss on Drying

Not more than 0.5%

Sulfated Ash

Not more than 0.1%

Heavy Metals

Not more than 20ppm

Residual Solvents

Alcohol: Not more than 0.2% Isopropyl Acetate: Not more than 0.2% Methanol: Not more than 0.1% Triethylamine: Not more than 0.1% Total Residual Solvents: Not more than 0.3%